MAUDE Adverse Event Report: CENTURION; TRIPLE LUMEN CVC KIT - 20CM

Catalog Number ECVC5400

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, after placing a central venous catheter device a "ct scan" showed retained guidewire fragments.The customer reported there was "nothing abnormal" noted regarding the product prior to the ct scan and the line was able to be "aspirated and flushed" without difficulty.The customer reported as a result of the reported incident the patient required retrieval of the fragments with an interventional radiology procedure.The customer reported the patient was also prescribed antibiotic therapy and home health care upon discharge.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, after placing a central venous catheter device a "ct scan" showed retained guidewire fragments.

• Type of Device: TRIPLE LUMEN CVC KIT - 20CM
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18016359
• MDR Text Key: 326674347
• Report Number: 3004519921-2023-00016
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10653160365891
• UDI-Public: 10653160365891
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECVC5400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other